37 Medical Affairs

Gregory P. Geba

37.1 Introduction

The role of clinical trials in evaluating efficacy and
safety of drugs extends well beyond the regulatory
environment of registration with health authorities.
Due to the tremendous costs and time associated
with drug development, the strategy involved in
drug registration is one that employs a process that
favors taking the most direct route to answer spe-
cific clinical efficacy and safety questions that
would allow health authorities to judge the bene-
fit–risk profile of a drug and secure marketing
approval for specific indications. It is, however,
rare that a drug has only one use, and almost
every new medicine can be employed in different
clinical scenarios, in different patient populations,
be studied to assess different clinical outcomes and
compared to other drugs of the same or other classes
in already approved indications. Such studies are
usually the focus of clinical research departments
that are organized under the rubric of ‘Medical
Affairs’ to distinguish them from ‘Clinical Devel-
opment’ departments that are focused on the sub-
mission of the New Drug Application (NDA).
Medical Affairs divisions are usually fully cap-
able research organizations housed within large
pharmaceutical companies, that are comprised of
medical, clinical and managerial staff (usually

healthcare-oriented clinical staff including physi-

cians, pharmacists, public health experts and statis-

ticians), as well as very extensive support staff that

includes clinical research associates (in-house or

field-based personnel who are the direct contacts

for investigational site interactions and communica-

tions), scientific liaisons, data analysis, medical

writing, regulatory and legal personnel. The goal of

such organizations is to allow pharmaceutical com-

panies to most effectively conduct clinical trials or

statistical analysis, prepare and submit data and

claims to regulatory authorities and disseminate

informationviameetings and symposia, and peer-

reviewed journals of high scientific value, enhancing

understanding and public health impact of marketed

medicines.

Medical Affairs departments are frequently

capable of conducting various types of clinical

research. The type of research culminating in the

further categorization of the efficacy and safety of a

new medicine can take the route of conventional

phase III clinical development, sometimes con-

ducted by a Medical Affairs division, whereby a

new indication is sought. Another approach is to

perform necessary clinical trials and seek approval

to promote features of benefit–risk that are sup-

ported by clinical data, with or without requesting

change of registered label use. This phase of

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9